BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q C-BLOC 400 ML, 2-14 ML/HR SAF

    MDR report key: 2508701 · Received March 26, 2012

    Report

    Report Number
    2026095-2012-00042
    Event Type
    Malfunction
    Date Received
    March 26, 2012
    Date of Event
    March 8, 2012
    Report Date
    March 14, 2012
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: SAMPLE HAS NOT YET BEEN RECEIVED, BUT WAS REPORTED TO BE AVAILABLE. RESULTS: WITHOUT THE ACTUAL PRODUCT, AN ANALYSIS CANNOT BE CONDUCTED. CONCLUSIONS: IF ADD'L INFO PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A F/U REPORT.

    Description of Event or Problem · 1

    DRUG/DILUENT: NAROPIN 0.20%. FILL VOLUME: 500ML. FLOW RATE: 4.0ML/HR. PROCEDURE: INTERSCALENE BLOCK. CATHPLACE: UNK. THE PT WENT HOME WITH THE PUMP THE DAY OF PROCEDURE, (B)(6) 2012. THE FLOW RATE WAS SET AT 4ML/HR, BY THE MORNING ON (B)(6) 2012 THE PUMP WAS COMPLETELY EMPTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q C-BLOC 400 ML, 2-14 ML/HR SAF ELASTOMERIC PUMP MEB I-FLOW CORPORATION 101347400 0200307070

    Patients

    Seq Age Sex Outcome Treatment
    1